FDA advises consumers on hand sanitizers
On June 19, the FDA advised consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol) – a substance that can be toxic when absorbed through the skin or ingested. The FDA has identified the following products manufactured by Eskbiochem:
– All-Clean Hand Sanitizer (NDC: 74589-002-01)
– Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
– CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
– Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
– The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
– CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
– CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
– CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
– Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)
The FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28 percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.
Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all people using the products on their hands are at risk, young children who accidentally ingest them and adolescents and adults who drink them as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
On June 17, the FDA contacted Eskbiochem to recommend the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. As of June 19, the company had not taken action to remove the products. Therefore, the FDA recommends consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush or pour the products down the drain.
As of June 19, the FDA was not aware of any reports of adverse events associated with the products. Health care professionals, consumers and patients are encouraged to report adverse events or quality problems to the FDA’s MedWatch Adverse Event Reporting program. Complete and submit the report at www.accessdata.fda.gov/scripts/medwatch/index.cfm, or download and complete the form, then submit it via fax to 1-800-FDA-0178 (800-332-0178).